What question did this study set out to answer?

To assess the efficacy and safety of the class III anti-arrhythmic drug nifekalant as an emergency therapy in patients with life-threatening, refractory ventricular tachycardia and fibrillation.

January 1, 2005Circulation JournalOpen Access

Emergency Treatment With Nifekalant, a Novel Class III Anti-Arrhythmic Agent, for Life-Threatening Refractory Ventricular Tachyarrhythmias Post-Marketing Special Investigation

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Why the study?

Does intravenous nifekalant terminate arrhythmias and prevent recurrence in patients with life-threatening refractory ventricular tachyarrhythmias?

Key Points

To assess the efficacy and safety of the class III anti-arrhythmic drug nifekalant as an emergency therapy in patients with life-threatening, refractory ventricular tachycardia and fibrillation.
A post-marketing special investigation was conducted involving an independent objective evaluation committee.
The committee re-evaluated clinical outcomes in 191 patients presenting with refractory ventricular tachycardia (VT) or ventricular fibrillation (VF) treated with nifekalant.
Direct arrhythmia termination occurred in 48.4% (45/93) of patients overall; among 39 patients with shock-resistant VT/VF, direct termination occurred in 9, and subsequent DC shock succeeded in 51.7% (15/29) of the remainder.
Recurrence prevention was achieved in 60.6% (60/99) of patients, while hemodynamic parameters showed a tendency to improve following maintenance infusion.
Corrected QT interval (QTc) prolonged from 0.463±0.056 to 0.504±0.072 after initial dosing and to 0.547±0.070 during maintenance infusion, with excessive prolongation in 11 patients and torsades de pointes in 3.

Structured PICO

Does intravenous nifekalant terminate arrhythmias and prevent recurrence in patients with life-threatening refractory ventricular tachyarrhythmias?

Population

191 patients with life-threatening refractory ventricular tachyarrhythmias (VT/VF), mean age 65.0, 158 male / 33 female. 182 had underlying heart disease (including acute myocardial infarction, old myocardial infarction, and cardiomyopathy) and 152 had severe heart failure.

Intervention

Nifekalant (intravenous single dose and/or maintenance infusion)

Outcome

Termination of sustained VT or VFhard clinical

Nifekalant is an effective emergency treatment for terminating and preventing recurrence of life-threatening refractory ventricular tachyarrhythmias, though careful QT monitoring is required.

Limitations

Not randomized
Done in a limited situation (observational post-marketing setting)

Authors

TKTakao KatohNippon Medical School HMHideo MitamuraTachikawa Hospital NMNaoki MatsudaTohoku Institute of Technology

Discussion

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Implication

May support nifekalant consideration for refractory VT/VF with QT caution; leaves open randomized confirmation of efficacy.

Cite This Study

Katoh et al. (2005) studied this question.

synapsesocial.com/papers/6a7f087777d355d255f0090e https://doi.org/10.1253/circj.69.1237

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Emergency Treatment With Nifekalant, a Novel Class III Anti-Arrhythmic Agent, for Life-Threatening Refractory Ventricular Tachyarrhythmias Post-Marketing Special Investigation

Key Points

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Emergency Treatment With Nifekalant, a Novel Class III Anti-Arrhythmic Agent, for Life-Threatening Refractory Ventricular Tachyarrhythmias Post-Marketing Special Investigation

Key Points

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Also Consider

Also Consider